Trial reportInternational urogynecology journal2018
A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results.
Trial report in International urogynecology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03763097 (Sonographic Evaluation of the Single-incision Needleless), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sonographic Evaluation of the Single-incision Needleless (Contasure-needleless®) Mini-sling Placement to Predict Success
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT.Health technology assessment (Winchester, England) · 2022Trial
- Evaluation of the efficacy of mini-sling in the treatment of stress urinary incontinence through patient-reported outcomes and transperineal ultrasonography.Journal of the Turkish German Gynecological Association · 2025Article
- Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.International urogynecology journal · 2024Article
- Long-Term Outcomes of the Altis® Single-Incision Sling: Up to 10 Years' Follow-up.International urogynecology journal · 2024Article
- Review
- Urinary Incontinence and Pelvic Organ Prolapse in Women.Deutsches Arzteblatt international · 2023Review
- Can the mini-sling become the golden standard for treating stress urinary incontinence?International urogynecology journal · 2021Article
- Comparison of outcomes of Burch colposuspension and transobturator tape and single incision needleless procedures (DynaMeshInternational urology and nephrology · 2020Article
- The International Urogynecological Association/International Continence Society classification of complications of prosthesis and graft insertion: Pros and cons and a review of the literatureJournal of the Turkish German Gynecological Association · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThere is a shortage of reliable data on the efficiency of the under-investigated mini-slings to treat stress urinary incontinence (SUI). We aimed to compare the effectiveness of the single-incision needleless mini-sling (SIMS) with the transobturator inside-out mid-urethral sling (TOT). MATERIALS AND
methodsTwo hundred one women with clinically proven SUI were included in this single-center prospective randomized trial. The patients were randomly allocated to the groups. All surgeries were done by the same single surgeon. Examinations were done by one other blinded surgeon. The patients were followed up for 24 months. Objective cure was defined as the absence of SUI and negative cough-stress test. Subjective cure was defined as no stress leakage of urine after surgery in a validated questionnaire. Failure of the surgery was defined as the need for reoperation. Every complaint was categorized by the IUGA/ICS Classification of Prosthesis-related Complications.
resultsThe objective (85.4% versus 89.9%, p = 0.362) and subjective (87.6% versus 89.9%, p = 0.636) cure rates were similar with the TOT and SIMS at the postoperative month 24, respectively. The mesh exposure ≤ 1 cm rate was 3.4% for both groups, and the mesh exposure > 1 cm rate was 2.2% for both groups. Overall failure rates were 3.4% and 2.2% for the TOT and SIMS group, respectively. No viscus organ perforation was noted. Complications with the SIMS procedure were less painful compared with TOT (p = 0.024).
conclusionsSingle-incision needleless mini-slings exhibited similar cure rates as the trans-obturator mid-urethral slings from both the patient and clinician points of view in 24 months of follow-up. Mini-slings resulted in significantly less postoperative pain than trans-obturator mid-urethral slings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.